Lot release and laboratory access
Course on lot release and laboratory access at the Biologics and Radiopharmaceuticals Evaluation Centre (BREC), Ottawa, Canada
The Biologics and Radiopharmaceuticals Evaluation Centre, formerly BBR, presents a five-day course on lot release and laboratory assessment and access. It is designed to provide the trainees with an understanding of the lot release system for bacterial and viral vaccines including the reasons for lot release of vaccines, procedural requirements and guidelines, the protocol review process, the requirement for testing, the characteristics required for a testing laboratory and the options available for external testing. Protocol review and testing requirements according to WHO summary protocols will be discussed for the following specific vaccines: pertussis, tetanus toxoid, combination vaccines, Haemophilus b conjugate vaccines, measles and oral poliomyelitis vaccines.
Agenda
Day 1 Day 2 Day 3 Day 4 Day 5
09:00 to 16:00
Lot release general
09:00 to 16:00
Lot release of bacterial vaccines
09:00 to 12:00
Lot release of viral vaccines
13:00 to 16:00
Visitation to vaccine laboratories in BREC and animal facility
(Banting Building)
09:00 to 15:00
Laboratory assessment and access
15:00 to 16:00
Preparation of trainees for description of existing system and
needs for respective country
09:00 to 12:00
Presentation by trainees and implementation
For further information please contact:
Dr Denise Denicourt
Head, Viral and Tumour Vaccines
Biologics and Radiopharmaceuticals Evaluation Centre (BREC)
3355 LCDC Tunney's Pasture
0603C Ottawa
Ontario K1A 0L2
Canada
Tel: 1 613 941 6057
Fax: 1 613 941 5841
Email: denise_denicourt@hc-sc.gc.ca
Dr Umit Kartoglü
GTN/VQ Coordinator
World Health Organization
IVB/QSS
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: 41 22 791 4972
Fax: 41 22 791 4384
Email: kartogluu@who.int